510(k) K081309 ยท JSS Kit, Identification, Enterobacteriaceae
E.COLI/P. AERUGINOSA PNA FISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | May 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081309
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.